Three and a Half Million Application Pages Submitted by GlobalSubmit Regulatory Services Over 30-Day Strech

Over a 30-day stretch in Q4 2016, GlobalSubmit’s Regulatory Services team submitted an impressive 3.5 million application pages.

Included in that total were 2 New Drug Applications (NDAs) submitted to the US FDA, one of which was submitted as a 505(b)(2). Each NDA represents the first marketing application filed for each company’s lead drug product candidate.

“Achieving such success in the face of multiple large, complex projects whose submission dates fell within days of each other demonstrates the capacity of our Regulatory Services team, our ability to plan long-term, and the level of productivity that’s possible with our software,” said Chief Technical Officer, Jason Rock. “These numbers show that GlobalSubmit is on par with any large-scale CRO from a productivity and resource standpoint.”

Personalized attention is also at a premium for clients who select GlobalSubmit as a regulatory outsourced publishing partner.

“Complications are inevitable in the final days of a major NDA submission project,” Rock added. “Both companies that submitted NDAs with us in Q4 2016 chose to have employees on-site at our Philadelphia headquarters during the submission deadline week to foster communication and create a tighter feedback loop. These projects are the culmination of years of effort and millions of dollars spent in development. Our goal is to get a quality submission in front regulators on time and to provide some peace of mind as the project nears completion.”

GlobalSubmit’s Regulatory Services team has experienced tremendous growth in the past few years and that growth will continue in 2017. We provide Regulatory Publishing services for NDAs, BLAs, MAAs, ANDAs, INDs, and maintenance submissions after the original filing.